# K983909: Mir Spirobank Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Mir Medical Intl. Research Srl
- Decided: Dec 21, 1998 after 48 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
41 later devices descend from it; 2 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K061712: Spirobank II (2006), 40 descendants of its own
- K072979: Spirobank G (2007), 33 descendants of its own
- K191272: Wearable Device, Wearable Package (2019), 16 descendants of its own
- K210133: Current Health Monitoring System Gen 2 (G2) (2021), 8 descendants of its own
- K221282: Empatica Health Monitoring Platform (2022), 7 descendants of its own

## Indications for use
Device is a spirometer for lung-function testing. For testing lung-function in people from children to adults, generally used by a physician or by a respiratory therapist or technician. Device is portable and thus can be used at home, in the factory, in the hospital, in the doctor's office.

Source page: https://510kreport.com/device/K983909
Methodology: https://510kreport.com/methodology